FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
84721–84744 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 21, 1999
HP VIRIDIA INFORMATION SYSTEM, MODELS M3150A/ M3151A/ M3153A/ M3154A
K993171 · DSI
Hewlett-Packard Co.
Cardiovascular · 30d
Cleared Oct 21, 1999
.010 SILVERSPEED HYDROPOPHILIC GUIDEWIRE, .014 SILVERSPED HYDROPHILIC...
K993257 · DQX
Micro Therapeutics, Inc.
Cardiovascular · 22d
Cleared Oct 20, 1999
TRIO 300
K990787 · IPF
Ito Co., Ltd.
Physical Medicine · 224d
Cleared Oct 20, 1999
CASE 8000 EXERCISE TESTING SYSTEM
K991014 · LOS
General Electric Medical Systems...
Cardiovascular · 208d
Cleared Oct 20, 1999
ACTIVA
K991132 · INI
Hoveround Corp.
Physical Medicine · 201d
Cleared Oct 20, 1999
125 IMPLANT SEEDS, MODEL STM1251
K991280 · KXK
Sourcetech Medical, LLC
Radiology · 189d
Cleared Oct 20, 1999
50 W METAL HALIDE ILLUMINATOR, VES 0501.
K992447 · FCW
Angiolaz, Inc.
Gastroenterology & Urology · 90d
Cleared Oct 20, 1999
BRAUN THERMOSCAN PRO3000 INFARED THERMOMETER
K992468 · FLL
Braun GmbH
General Hospital · 89d
Cleared Oct 20, 1999
AMBIDERM LATEX EXAMINATION GLOVES (VIOLET, BLUE , GREEN, AND PINK) CONTAINING...
K993080 · LYY
Medtexx Partners, Inc.
General Hospital · 36d
Cleared Oct 20, 1999
BALLARD MIC-KEY G LOW PROFILE GASTROSTOMY REPLACEMENT KIT
K993138 · KNT
Ballard Medical Products
Gastroenterology & Urology · 30d
Cleared Oct 20, 1999
QUICKSCREEN PRO MULTI DRUG SCREEN, MODEL 9177 & 9178
K993165 · DJG
Phamatech
Toxicology · 28d
Cleared Oct 19, 1999
LIGHT DIAGNOSTICS SIMULFLUOR HSV/VZV IMMUNOFLOURESCENCE ASSAY, MODEL 3295
K990141 · GQW
Light Diagnostics
Microbiology · 273d
Cleared Oct 19, 1999
TES-20
K992425 · MWJ
Tes Electrical Electronic Corp.
Cardiovascular · 90d
Cleared Oct 19, 1999
PASCO MIC AND MIC/ID PANELS, PENICILLIN
K992646 · JTN
Pasco Laboratories, Inc.
Microbiology · 74d
Cleared Oct 19, 1999
PASCO MIC AND MIC/ID PANELS, ERYTHROMYCIN
K992647 · JTN
Pasco Laboratories, Inc.
Microbiology · 74d
Cleared Oct 19, 1999
MCL 29 DERMABLATE ER:YAG LASER SYSTEM
K992707 · GEX
Aesculap-Meditec North America
General & Plastic Surgery · 69d
Cleared Oct 19, 1999
P.A.S. PORT ELITE IMPLANTABLE VENOUS ACCESS SYSTEM
K992880 · LJT
Sims Deltec, Inc.
General Hospital · 53d
Cleared Oct 18, 1999
DERMAGRIP POWDER FREE NITRILE EXAMINATION GLOVE, NON STERILE
K990752 · LZA
Wrp Specialty Products Sdn. Bhd.
General Hospital · 224d
Cleared Oct 18, 1999
VIP 60 (2H), MODEL 115-000-1, VIP 60 (4H), MODEL 115-000-2
K991239 · ELC
Micron Corp.
Dental · 189d
Cleared Oct 18, 1999
OPAP
K991926 · BZD
Opap, Inc.
Anesthesiology · 133d
Cleared Oct 18, 1999
RAPIDONE-AMPHETAMINE TEST
K992452 · DOD
American Bio Medica Corp.
Toxicology · 88d
Cleared Oct 18, 1999
HEALTH-PLUS SANITEX,RELIANCE PRE-POWDERED MULTI-PLY LATEX EXAMINATION GLOVE...
K992523 · LYY
Pamitex Industries Sdn Bhd
General Hospital · 82d
Cleared Oct 18, 1999
PHILIPS GYROSCAN INTERA (*)
K992533 · LNH
Philips Medical Systems North...
Radiology · 81d
Cleared Oct 18, 1999
FETAL ASSESSMENT CAP
K992580 · IYO
Acuson Corp.
Radiology · 77d